The Biomarker Experimental Medicine Leader (BEML) – Ophthalmology, will be accountable for developing and delivering molecular and imaging biomarker strategies within NORD in particular Ophthalmology. This includes enabling testing of biological and clinical hypothesis, including methods for establishing target engagement, Pharmaco-dynamic responses, patient selection and stratification and measuring disease progression.
The remit includes programs from late preclinical through Phase 3 and preparation for market authorization and filing. You will develop therapeutic area biomarker strategy and contribute to therapeutic strategy of Ophthalmology and Lead biomarker subteams and be a member of clinical and project teams as applicable.
You will be accountable for molecular and imaging biomarker data in trials involving blood- and Aqueous humour-based assays, ensuring standardization of methodologies across sites and countries, highest data QC, monitoring of sites and CROs, and protocol compliance
- Guide diagnostic biomarker development and PHC strategy
- Design, edit, write and review protocols and study reports for experimental medicine and clinical pharmacology studies from early proof-of-concept through global Phase III
- Work with statisticians on analysis plans involving molecular and imaging biomarker endpoints.
- Liaise closely with cross-functional study team members, providing expert input on data review and interpretation
- Explore and develop novel opportunities to integrate biomarker studies into late stage development
- Publish data in top-tier journals, attend and present at international meetings